Kornimate/medical-research-clean huggingface dataset:
tegafur-uracil or observation in treating patients with stage ii colorectal cancer that has been completely removed by surgery

Conditions: Colorectal Cancer

Summary: rationale: drugs used in chemotherapy, such as tegafur-uracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. giving chemotherapy after surgery may kill any tumor cells that remain after surgery. sometimes, after surgery, the tumor may not need more treatment until it progresses. in this case, observation may be sufficient. it is not yet known whether chemotherapy is more effective than observation in treating colorectal cancer. purpose: this randomized phase iii trial is studying tegafur and uracil to see how well they work compared to observation in treating patients with stage ii colorectal cancer that has been completely removed by surgery.

objectives: primary * compare the efficacy of adjuvant tegafur-uracil vs observation only in patients with curatively resected stage ii colorectal cancer. secondary * compare relapse-free and overall survival of patients treated with these regimens. * compare the occurrence of adverse events in patients treated with these regimens. outline: this is a randomized, controlled study. patients are randomized to 1 of 2 treatment arms. * arm i: patients undergo observation. * arm ii: patients receive oral tegafur-uracil on days 1-5. treatment repeats every 7 days for 1 year in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed periodically for 5 years. projected accrual: a total of 2,000 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the colon or rectosigmoid * stage ii disease * has undergone curative (r0) resection within the past 8 weeks * no suspicion of hereditary colorectal cancer * no severe postoperative complications patient characteristics: * ecog performance status 0-1 * wbc 3,500-12,000/mm³ * absolute neutrophil count ≥ 1,500/mm³ * platelet count ≥ 100,000/mm³ * hemoglobin ≥ 9.0 g/dl * bilirubin ≤ 2.0 mg/dl * ast and alt ≤ 100 iu/l * creatinine ≤ 1.5 mg/dl * not pregnant or nursing * able to take oral medications * major organ functions are preserved * no other active malignancy * none of the following conditions: * uncontrolled diabetes mellitus * uncontrolled hypertension * myocardial infarction or unstable angina pectoris within the past 6 months * liver cirrhosis * interstitial pneumonia * pulmonary fibrosis * severe emphysema * no psychiatric disease or other condition that would preclude study participation prior concurrent therapy: * see disease characteristics * no prior chemotherapy * no prior or concurrent radiotherapy * no concurrent prophylactic growth factors * no concurrent biologic response modifiers

Keywords: stage ii colon cancer stage ii rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum
phase 2 study of irinotecan liposome injection, oxaliplatin, 5-fluorouracil/levoleucovorin in japanese participants not previously treated for metastatic adenocarcinoma of the pancreas

Conditions: Metastatic Adenocarcinoma of the Pancreas

Summary: this study is to assess the anti-tumour activity, safety and tolerability of irinotecan liposome injection (s095013) in combination with oxaliplatin, 5-fluorouracil (5-fu) and levoisomer form of leucovorin (llv). s095013, oxaliplatin, 5-fu and llv will be administered on days 1 and 15 of each 28-day cycle. cycles will continue until clinical or radiological progressive disease, unacceptable study medication-related toxicity or withdrawal from study. during the treatment period participants will have study visits on day 1, 3, 15, and 17 of each cycle, some of which may occur as a home visit. at least 30 days after treatment has ended a end of treatment visit will occur and then participants will be followed for survival every month via telephone or email until death or end of the study. study visits may include questionnaires, blood and urine tests, ecg, vital signs, physical examination, and administration of study treatment.


Eligibility criteria:
inclusion criteria: * male or non-pregnant and non-lactating female ≥ 18 years of age. * histologically or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting. * initial diagnosis of metastatic disease (as per american joint committee on cancer 8th edition \[ajcc 2017\]) must have occurred ≤ 6 weeks prior to screening. * participant has one or more metastatic lesions measurable by ct-scan (or mri), if the participant is allergic to ct contrast media, according to recist version 1.1 criteria. * ecog ps of 0 or 1 at screening and within 7 days prior to first dosing. * participant has adequate hematological, biochemical, hepatic, and renal function parameters. exclusion criteria: * prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy (palliative surgery, palliative radiotherapy and placement of biliary stent/tube are permitted). * prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related relevant toxicities are present. * participant has only locally advanced disease. * known hypersensitivity to any of the components of irinotecan liposome injection, other liposomal products, or any components of 5-fu, llv or oxaliplatin products.
perioperative pregabalin and lidocaine to reduce chronic breast cancer pain

Conditions: Post-mastectomy Pain Syndrome; Chronic Post-surgical Pain

Summary: breast tissue and the areas surrounding the breast contain many small to medium-sized nerves. during surgery on the breast, these nerves can be inadvertently cut or damaged. chemotherapy and radiotherapy after surgery worsen the injury experienced by these nerves. these nerves eventually become abnormal and provide pain signals to the brain well beyond the healing period after surgery. patients with these abnormal nerves suffer from chronic pain in the breast area that persists for several years after surgery. chronic pain is associated with a reduced quality of life, daily functioning, psychological distress, and contributes to excessive health care expenditures. there is encouraging data suggesting that an infusion of lidocaine during surgery and pregabalin given around the time of surgery can prevent the development of chronic pain after breast cancer surgery. a large randomized controlled trial is needed to determine the efficacy of these two interventions on reducing chronic pain after breast cancer surgery (e.g. within 3 months of surgery). a pilot trial is first needed to determine the feasibility of undertaking such a trial.


Eligibility criteria:
inclusion criteria: * female patients 18-75 years of age * undergoing a unilateral or bilateral mastectomy or partial-mastectomy (breast conserving surgery), for prophylactic (e.g. family history or brca gene mutation) or belief of isolated (non-metastatic) cancerous lesions * receiving a general anesthetic exclusion criteria: * previous breast surgery within six months of index surgery * undergoing a diep (deep inferior epigastric perforator) flap procedure * patient has chronic pain or a chronic pain syndrome for which they have taken 4 or more daily medications (i.e. opioids, anti-convulsants, anti-spasmodic, anti-depressants, anti-inflammatories) or routine pain intervention (i.e. nerve blocks) during the past 3 months * documented hypersensitivity or allergy to pregabalin, gabapentin, or lidocaine * history of ventricular tachycardia, ventricular fibrillation, or atrioventricular block ≥ type ii * history of congestive heart failure * renal insufficiency with creatinine \> 120 µmol/l * known or previously documented cirrhosis * pregnant * unable to swallow study medications * patient's surgeon believes patient is inappropriate for inclusion in trial * unlikely to comply with follow-up (e.g. no fixed address, plans to move out of town) * language difficulties that would impede valid completion of questionnaires * patient requires gabapentin or pregabalin for a medical condition or has been taking gabapentin or pregabalin daily during the past 1 week
a study to evaluate the effect of rifampin on pharmacokinetics of pf-06463922 in healthy volunteers

Conditions: Healthy

Summary: the purpose of this study is to estimate the effect of rifampin on the single dose pk of pf-06463922.

this will be a phase 1, open-label, 2-period, 2-treatment, fixed-sequence, cross-over study in approximately 12 healthy subjects employing administration of a single oral dose of pf-06463922 in the fasted state alone, and with multiple dosing of rifampin 600 mg once a day to estimate the effect of multiple dose rifampin on the single dose pk of pf-06463922.

Eligibility criteria:
inclusion criteria: * healthy female subjects of non-childbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs) exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease * any condition possibly affecting drug absorption * positive urine drug screen * history of hiv, hep b or hep c * history of regular alcohol consumption * history of cardiac arrhythmia, history of av block, history of symptomatic bradycardia, history of qtc prolongation * history of pancreatitis or hyperlipidemia, elevated lipase

Keywords: rifampin pharmacokinetics pf-06463922 drug interaction
comparison between amniotic fluid lamellar body count and fetal pulmonary artery doppler indices in predicting fetal lung maturity

Conditions: Preterm Labour

Summary: the investigators will study 200 women with singleton pregnancies presented with prelabor preterm rupture of membranes or undergoing cesarean section (cs). amniotic fluid lamellar body count (lbc) and fetal pulmonary artery doppler will be done to all women. lbc and fetal pulmonary artery doppler will be correlated with fetal outcome

neonatal respiratory distress syndrome (rds) remains a major cause of neonatal morbidity and mortality. a recent epidemiologic study in the united states estimates that there are 80,000 cases of neonatal rds each year, resulting in 8500 deaths and hospital costs in excess of $4.4 billion. a number of biochemical tests have been developed to predict the risk of rds and assist obstetric care providers in delivery timing. amniotic fluid lamellar body count (lbc) is an important biophysical test, based on measuring the concentration of pulmonary surfactant in amniotic fluid. it can be effectively used to assess fetal lung maturity. a noninvasive test for fetal lung maturity (flm) would be useful to minimize the need for invasive testing and would be more acceptable to women. fetal pulmonary artery doppler waveform acceleration/ejection time may provide a noninvasive means of determining fetal lung maturity with relatively acceptable levels of sensitivity, specificity, and predictive values. the investigators will study 200 women with singleton pregnancies presented with prelabor preterm rupture of membranes or undergoing cesarean section (cs). amniotic fluid lamellar body count (lbc) and fetal pulmonary artery doppler will be done to all women. lbc and fetal pulmonary artery doppler will be correlated with fetal outcome. quantitative data will be statistically represented in terms of mean ± standard deviation (± sd) while categorical data will be represented as frequency and percentage. comparison of quantitative data will be done using mann whitney u test for independent samples while categorical data will compared using chi squared test or fisher exact test when appropriate. a probability value (p value) less than 0.05 will be considered significant.

Eligibility criteria:
inclusion criteria: * singleton pregnancies without any major congenital anomalies. * gestation between 32-36 weeks * women presenting preterm pre-labour ruptured membranes or undergoing a cesarean section. exclusion criteria: * patients with major fetal anomalies. * bloody or meconium stained amniotic fluid * preexisting maternal medical conditions (eg, diabetes, renal disease, hypertensive disorders, vaginal bleeding
thyroid hormones treatment in asthma exacerbation

Conditions: Asthma

Summary: this study will explore whether supplementation with thyroid hormones in the set-up of asthma exacerbation could improve the clinical outcomes. the study will include adults admitted to rambam health care campus for moderate to severe asthma exacerbation. the study is a prospective, randomized, double-blind, placebo-controlled, clinical trial. patients will be randomized on admission to receive treatment with intra-venous thyroxine (100mcg once on admission and additional 100mcg after 12 hours) or placebo. the study treatment will be given only after the initial bronchodilator therapy, oxygen and informed consent are given. the primary endpoint is the time to return of the peak expiratory flow (pef) rate to normal values or personal base line.

study population: the study will include adults admitted to internal medicine b (imb) department, internal medicine h (imh) department or medical intensive care unit (micu) in rambam-health care campus for moderate to severe asthma exacerbation. the severity of the exacerbation will be based on several acceptable clinical and laboratory criteria, including breathless, alertness, pulse rate, respiratory rate, partial pressure of oxygen in arterial blood (pao2), partial pressure of carbon dioxide in arterial blood (paco2), oxygen saturation, peak expiratory flow (pef). study protocol: the study is a prospective, randomized, double-blind, placebo-controlled, clinical trial. patients will be randomized on admission to receive treatment with intra-venous thyroxine (100mcg once on admission and additional 100mcg after 12 hours) or placebo. the study treatment will be given only after the initial bronchodilator therapy, oxygen and informed consent are given. the primary endpoint is the time to return of the pef rate to normal values or personal base line. pef rates will be examined first after initial bronchodilator therapy and then, every 8 hours.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * known asthma * the exacerbation is defined as moderate or severe. * not currently enrolled as an active participant in another clinical trial of a medical therapy or device. * the patient or first degree family relative (in cases where the patient is intubated) has authorized his/her consent to participate in this trial. the patient will be asked to give his consent only after initial bronchodilator therapy exclusion criteria: * 60 years of age or older * known thyroid disorders * subject where thyrotoxicosis is suspected * known heart disease * heart rate \> 140

Keywords: asthma thyroid hormones treatment asthma exacerbation
chewing versus traditional oral administration of ticagrelor in stemi patients

Conditions: Acute Coronary Syndromes; ST Elevation Myocardial Infarction

Summary: to examine chewing versus traditional oral administration of ticagrelor in st-elevation myocardial infarction (stemi) patients on platelet reactivity.


Eligibility criteria:
inclusion criteria: 1. patients presenting with stemi 2. informed, written consent exclusion criteria: 1. age \ 90 years 2. active bleeding; bleeding diathesis; coagulopathy 3. increased risk of bradycardic events 4. history of gastrointestinal or genitourinary bleeding \<2 months 5. major surgery in the last 6 weeks 6. history of intracranial bleeding or structural abnormalities 7. suspected aortic dissection 8. any other condition that may put the patient at risk or influence study results or investigator's opinion (severe hemodynamic instability, unconsciousness, known malignancies or other comorbid conditions with life expectancy \<1 year) 9. administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux. 10. concomitant oral or iv therapy with strong cyp3a inhibitors or strong cyp3a inducers, cyp3a with narrow therapeutic windows 11. known relevant hematological deviations: hb \<10 g/dl, plt\<100x10\^9/l 12. use of coumadin derivatives within the last 7 days 13. chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine 14. known severe liver disease, severe renal failure 15. known allergy to the study medications 16. pregnancy 17. human immunodeficiency virus treatment 18. the use of iibiiia receptor antagonists in the 48 hours before enrollment (if abciximab use then in the last 14 days). 19. if the patients cannot sign percutaneous coronary intervention (pci) informed consent for any reason.

Keywords: stemi
a study for long-term follow-up of hemophagocytic lymphohistiocytosis (hlh) participants who received treatment with emapalumab (ni-0501), an anti-interferon gamma monoclonal antibody

Conditions: Hemophagocytic Lymphohistiocytosis

Summary: international, multicenter, long-term, follow-up study that will enrol hlh participants who have received emapalumab in previous clinical trials, in the context of the clinical development program for emapalumab or under compassionate use (cu).

the aim of this study is to monitor the long-term safety profile of emapalumab in participants who have previously received at least one dose of emapalumab, including survival time after the administration of emapalumab. moreover, the elimination profile of emapalumab and the immunogenicity will also be assessed. furthermore, safety, tolerability, efficacy, and pharmacokinetic (pk) profile of emapalumab will be closely monitored in the event that some participants, upon request of the treating physician, will receive emapalumab treatment in the follow-up study.

Eligibility criteria:
inclusion criteria: * having received at least one dose of emapalumab. * having signed the informed consent by the participant or the participant's legal representative(s), as applicable, with the assent of participant who are legally capable of providing it. exclusion criteria: * none

Keywords: hemophagocytic lymphohistiocytosis (hlh) previously treated with ni-0501 emapalumab
a sustainable diet for hadassah employees workers

Conditions: Obesity; Physical Activity

Summary: the aim of this protocol is to use a multidisciplinary approach to convey nutrition and activity messages to randomly selected hadassah medical center employees. the intervention will be for one academic year and include frontal talks, email and internet focus group interactions, public demonstrations and a focused intervention within the hospital kitchen. the outcomes are specific parameters of dietary modifications, degree of physical activity and health related perspectives. outcomes will be recorded at baseline and by the end of the intervention ( one year).

the participants will be selected randomly from the campus employees. they will be exposed to multiple levels of health promotion at the work place as well as via multiple media tools. analysis will be performed at baseline by using multiple nutrition and health perception questionnaires. a second group from the employees will be selected for assessment of the same outcomes at the end of the year.

Eligibility criteria:
inclusion criteria: hadassah medical center employees age 21-67 - exclusion criteria: - refusal to participate

Keywords: sustainable diet health promotion obesity
reversibility of methacholine induced bronchoconstriction

Conditions: Asthma

Summary: the study will compare salbutamol reversibility of methacholine induced bronchoconstriction between a pressurized metered dose inhaler with a spacer versus nebulizer administration using a vibrating mesh nebulizer.


Eligibility criteria:
inclusion criteria: * age (years) at least 18, male or female * no confounding health issue (i.e. no health conditions, other than asthma, that would put the participant at risk or affect data integrity) * baseline fev1 ≥ 65% predicted (per quanjer gli 2012) * methacholine pd20 ≤ 800mcg exclusion criteria: * respiratory infection within 4 weeks of visit 1 * exposure to triggers of respiratory symptoms within 4 weeks of visit 1 * currently pregnant or breastfeeding * current smoker (cigarettes, vaping)
electroencephalogram (eeg) and electroconvulsive therapy(ect) response in schizophrenia

Conditions: Schizophrenia

Summary: this study is designed to find quantitative electroencephalogram(qeeg) biomarkers to predict electroconvulsive therapy(ect) response in schizophrenia

the purpose of this proposal is to explore quantitative electroencephalogram(qeeg) biomarkers that would predict electroconvulsive therapy(ect) response in schizophrenia (szd). the investigators will recruit 30 szd patients who are preparing for ect treatment and assesse psychotic symptoms using positive and negative symptom scale(panss) before and after 8-sessions clinical course of ect treatment. these patients needed ect treatment are assessed by clinicians according to american psychiatric association(apa) guidelines. meanwhile resting eeg will be recorded for 10 minutes before the first episode of ect treatment. decrease of panss scores will be calculated after the last session of ect treatment to distinguish responder/non-responder.

Eligibility criteria:
inclusion criteria: * dsm-5 criteria for szd * patients needed ect treatment assessed by clinicians using american psychological association(apa) guidelines. * symptoms must be of at least moderate severity (panss score \>71) * age between 18 to 60 years old * medications will be stable for at least four weeks prior to ect, and there will be no dose changes unless medically necessary exclusion criteria: * any additional current psychiatric comorbidity * pregnancy or prepare to have a baby * current use of any antiepileptic drugs * history of taking any kinds of physicotherapeutics within 6 months * severe psychotic symptoms that make patients could not accomplish the clinical interview